The Screening Visit
The screening visit is usually the longest and most complete of the subject visits. At the beginning of the visit, a complete demographic form should be collected. For future follow-up, all phone numbers, email addresses, names of four friends and family members, and names and contact information for physicians should be listed. A picture of the subject (which may be on a driver’s license) and a medical release form should be completed. The medical history form should contain information on medical illnesses, lifestyle, family history, psychosocial history, and review of systems, all of which should be reviewed with the subject. The medication bottles should be reviewed, and a list of all concomitant medications should be compiled. The chart template should also include sections for the phone correspondence, con meds, AE and SAE lists, study endpoints, protocol deviation log, study drug dispensing log, IVRS randomization contacts, inclusion and exclusion criteria, and patient consents.